Data Request Number:
Is the scientific purpose of the research proposal clearly described?:
Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?:
Can the proposed research be reasonably addressed using the requested data?:
Yes, or it’s highly likely
Please use this space to provide any comments, feedback or concerns (optional):
This is a useful secondary analysis of the REACH trial, determining whether serum infliximab concentration is associated with improved outcomes among pediatric patients with moderate-to-severe Crohn’s disease. My only concern is whether serum infliximab concentrations were collected at weeks 2, 6 and 10, as needed by the investigators. This should be confirmed with the clinical trial team at Janssen.
Recommendation for this data request: